Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-31 @ 6:29 PM
Study NCT ID:
NCT04899167
Status:
COMPLETED
Last Update Posted:
2023-10-05
First Post:
2021-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Noninvasive Evaluation of Renal Allograft Fibrosis by MRI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-17', 'size': 482885, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-10-03T14:50', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, unblinded, Parallel, imaging study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-03', 'studyFirstSubmitDate': '2021-05-19', 'studyFirstSubmitQcDate': '2021-05-19', 'lastUpdatePostDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The values and correlation of f with IF', 'timeFrame': '2 years', 'description': 'Correlation of qMT with tissue fibrosis (trichrome)'}], 'secondaryOutcomes': [{'measure': 'The correlation of f with renal function attributes and pro-fibrogenic activity', 'timeFrame': '2 years', 'description': 'Correlation of qMT with renal oxygenation, GFR, levels of fibrogenic factors.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Transplantation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to validate an MRI method to detect renal fibrosis in patients after kidney transplantation (KT).', 'detailedDescription': 'The hypothesis underlying this proposal is that qMT reliably detects development of allograft fibrosis in human subjects after KT. To test this hypothesis, the qMT-derived bound pool fraction will be correlated with renal fibrosis as per biopsy in 20 patients 4 or 7 years after living donor KT. The bound pool fraction will also be compared to renal blood flow, oxygenation, and function, and the ability of qMT to provide consistent assessments of fibrosis tested at different magnetic field strengths. Two specific aims will test the hypotheses that: Specific Aim 1: qMT provides reliable and consequential assessment of fibrosis in human kidney allografts. Specific Aim 2: Renal fibrosis assessed by qMT in human kidney allografts is reproducible at 1.5 T and 3.0 T.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-80 years\n* Recipient of living donor kidney transplantation 4 or 7 years earlier\n* Competent and able to provide written informed consent; Ability to comply with protocol\n\nExclusion Criteria:\n\n* Patients have clinically significant medical conditions within the prior 6 months before: e.g. myocardial infarction, congestive heart failure, stroke, that would, in the opinion of the investigators, compromise the safety of the patient.\n* Severe chronic liver, heart or lung disease\n* Undergoing acute rejection\n* Contra-indication to biopsy; bleeding disorders\n* Chronic infection\n* Any active malignancy and undergoing therapy\n* Kidney or ureteric stone\n* Unable to give valid informed consent\n* Known pregnancy or intent to conceive during the study period\n* Pacemaker, implantable defibrillator, magnetically active metal fragments, claustrophobia or other contraindication to MRI\n* Federal medical center inmates.\n* Latex allergy'}, 'identificationModule': {'nctId': 'NCT04899167', 'briefTitle': 'Noninvasive Evaluation of Renal Allograft Fibrosis by MRI', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Noninvasive Evaluation of Renal Allograft Fibrosis by MRI', 'orgStudyIdInfo': {'id': '19-008333'}, 'secondaryIdInfos': [{'id': 'R21AG062104', 'link': 'https://reporter.nih.gov/quickSearch/R21AG062104', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '4 years after kidney transplantation', 'description': 'Patients 4 years after KT (N=10); 5 with estimated (e) glomerular filtration rate (GFR) ≤35 mL/min/1.73m2, and 5 with estimated (e) glomerular filtration rate (GFR)\\>35 mL/min/1.73m2.', 'interventionNames': ['Other: MRI 1.5T and 3.0T']}, {'type': 'EXPERIMENTAL', 'label': '7 years after kidney transplantation', 'description': 'Patients 7 years after KT (N=10); 5 patients with eGFR ≤35 mL/min/1.73m2, and 5 with eGFR\\>35 mL/min/1.73m2.', 'interventionNames': ['Other: MRI 1.5T and 3.0T']}], 'interventions': [{'name': 'MRI 1.5T and 3.0T', 'type': 'OTHER', 'description': 'Magnetic Resonance Imaging for Renal Fibrosis', 'armGroupLabels': ['4 years after kidney transplantation', '7 years after kidney transplantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Lilach Lerman, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Lilach O Lerman', 'investigatorAffiliation': 'Mayo Clinic'}}}}